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Viral infectious disease IVDs - ARTG 248313

Access comprehensive regulatory information for Viral infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 248313 and sponsored by Key Diagnostics Pty Ltd, manufactured by Microgen Bioproducts Limited in United Kingdom. The device registration started on July 16, 2015.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 248313
Class IIa
Viral infectious disease IVDs
ARTG ID: 248313
Good Name: Key Diagnostics Pty Ltd - Viral infectious disease IVDs
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Intended Purpose

CT355 Viral infectious disease IVDs. For rotavirus and adenovirus antigen detection in stool for laboratory use only.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
248313
Start Date
July 16, 2015
Effective Date
July 16, 2015
Manufacturer
Country
United Kingdom
Address
1 Admiralty Way, CAMBERLEY , SURREY, GU15 3DT